PHENOBARBITAL for Neonatal seizure: Side Effects & Safety Data

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There are 92 adverse event reports in the FDA FAERS database where PHENOBARBITAL was used for Neonatal seizure.

Most Reported Side Effects for PHENOBARBITAL

Side Effect	Reports	%	Deaths	Hosp.
Drug ineffective	1,686	26.0%	154	781
Off label use	781	12.1%	96	387
Seizure	620	9.6%	37	231
Multiple-drug resistance	406	6.3%	27	67
Toxicity to various agents	392	6.1%	219	172
Status epilepticus	317	4.9%	33	136
Drug reaction with eosinophilia and systemic symptoms	274	4.2%	25	197
Foetal exposure during pregnancy	266	4.1%	14	46
Hypotension	256	4.0%	22	155
Epilepsy	253	3.9%	13	104
Drug resistance	233	3.6%	10	47
Product use in unapproved indication	230	3.6%	20	139
Drug abuse	227	3.5%	61	150
Condition aggravated	223	3.4%	16	114
Product use issue	207	3.2%	4	126